Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003968
First received: November 1, 1999
Last updated: February 7, 2013
Last verified: January 2004

November 1, 1999
February 7, 2013
June 1999
December 2003   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00003968 on ClinicalTrials.gov Archive Site
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Bryostatin 1 in Treating Patients With Metastatic Kidney Cancer
Phase II Study of Bryostatin-1 in Metastatic Renal Cell Carcinoma(Summary Last Modified 8/1999)

Phase II trial to study the effectiveness of bryostatin 1 in treating patients who have metastatic kidney cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

OBJECTIVES:

I. Determine the objective response rate to bryostatin 1 in patients with advanced renal cell carcinoma.

II. Assess the toxicities of this treatment regimen in this patient population. III. Determine the time to disease progression in patients receiving this treatment regimen.

IV. Determine the overall survival of this patient population treated with this regimen.

OUTLINE:

Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

Interventional
Phase 2
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Kidney Cancer
Drug: bryostatin 1
Experimental: Arm I
Patients receive bryostatin 1 IV over 1 hour on days 1, 8, and 15. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progresssion.
Intervention: Drug: bryostatin 1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
35
Not Provided
December 2003   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Histologically confirmed metastatic renal cell carcinoma
  • Bidimensionally measurable disease
  • Clear evidence of progression if only site of measurable disease is within previous radiation port
  • Previously irradiated brain metastases allowed, if not life threatening, symptoms controlled for 3 months, and not requiring corticosteroids

PATIENT CHARACTERISTICS:

  • Age: 18 and over
  • Performance status: ECOG 0-1
  • Life expectancy: Greater than 3 months
  • WBC at least 3,000/mm3
  • Platelet count at least 100,00/mm3
  • Bilirubin no greater than 1.5 mg/dL
  • Creatinine no greater than 2.0 mg/dL OR creatinine clearance greater than 50 mL/min
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception for 1 month before, during, and for 3 months after study
  • No active bacterial or viral infection
  • No serious underlying medical condition that would interfere with compliance
  • No other malignancy within the past 5 years except basal cell carcinoma of the skin
  • No dementia or altered mental status that would prevent informed consent

PRIOR CONCURRENT THERAPY:

  • No more than 1 prior therapy with biologic response modifiers
  • No prior chemotherapy for advanced disease
  • No other concurrent chemotherapy
  • No concurrent steriods (except topical use)
  • At least 4 weeks since prior radiotherapy
  • No concurrent radiotherapy
  • At least 4 weeks since major surgery (including nephrectomy)
  • No other concurrent experimental agents
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00003968
NCI-2012-02303, FCCC-99012, NCI-T99-0002, CDR0000067169
Not Provided
National Cancer Institute (NCI)
National Cancer Institute (NCI)
Not Provided
Study Chair: Naomi S. Balzer-Haas, MD Fox Chase Cancer Center
National Cancer Institute (NCI)
January 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP